Education and Training
Study of BDC-3042 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Malignancies
A first-in-human study using BDC-3042 as a single agent and in combination with pembrolizumab in patients with advanced malignancies
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: BDC-3042
- drug: Pembrolizumab
Eligibility
Inclusion Criteria:
1. Able to understand and sign the informed consent form
2. Age 18 years or older at the time of informed consent
3. Has disease that is measurable by Response Evaluation Criteria in Solid Tumors
(RECIST) v.1.1
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Subjects enrolled in Part 1 and Part 2 dose escalation cohorts must have:
a. Histologically/cytologically confirmed triple-negative breast cancer (TNBC), clear
cell renal cell cancer (ccRCC), ovarian cancer, head and neck cancer, colorectal
cancer, or non-small cell lung cancer (NSCLC) that is metastatic or unresectable with
tumor progression after standard therapy who have no options for standard therapies
which are known to confer clinical benefit. Subjects with ovarian cancer must have
platinum resistant or platinum-refractory tumors.
6. Subjects enrolled in Part 3 and Part 4 dose expansion cohorts must have
histologically/cytologically confirmed metastatic or unresectable TNBC or NSCLC with
tumor progression after standard therapy who have no options for standard therapies
which are known to confer clinical benefit.
7. Adequate organ function defined as follows:
1. Hematology: i. Absolute neutrophil count ≥ 1500 cells/mm3; ii. Platelet count ≥
75,000 cells/mm3; iii. Hemoglobin ≥ 9 g/dL (and without transfusion within 7
days)
2. Renal: creatinine clearance ≥ 30 mL/min by Cockcroft-Gault estimate
3. Coagulation: Prothrombin time or international normalized ratio and activated
partial thromboplastin time ≤ 1.5 × upper limit of normal (ULN) (unless receiving
anticoagulation therapy)
4. Hepatic: i. Aspartate aminotransferase and alanine transaminase (ALT) ≤ 3 × ULN
(or ≤ 5 × ULN in subjects with known hepatic metastases); ii. Total bilirubin ≤
1.5 × ULN (isolated value > 1.5 × ULN is acceptable if direct bilirubin is < 35%
of total)
8. Developed tumor progression after treatment with all standard therapies or have no
appropriate available therapies
9. Expected life expectancy of > 12 weeks per the Investigator
10. Women of childbearing potential (WOCBP) should use a highly effective contraceptive
measure (a method that can achieve a failure rate of less than 1% per year) during
treatment and until 4 weeks after the end treatment.
11. Potent men that are partners of WOCBP must be willing to use condoms in combination
with a second highly effective method of female contraception and agree not to donate
sperm from screen through at least 4 months after last dose of study treatment. A male
partner will be considered as potent unless surgically sterilized (with appropriate
documentation of sterility).
Exclusion Criteria:
1. Active systemic yeast infection within 4 weeks before study treatment
2. Prior hospitalization for asthma during past year
3. Central nervous system metastases except for disease that is asymptomatic, clinically
stable, and has not required steroids for at least 14 days before starting study
treatment
4. Cardiac disease including:
1. Congestive heart failure New York Heart Association classes II-IV
2. QTcF prolongation > 450 milliseconds (ms) based on a 12-lead electrocardiogram
(ECG) in triplicate or > 480 ms for subjects with bundle branch block
3. Serious or uncontrolled cardiac arrhythmia within 6 months before starting study
treatment
4. Myocardial infarction, unstable angina pectoris, or coronary angioplasty,
stenting, or surgery within 6 months before starting study treatment
5. Serious or uncontrolled hypertension (≥ 180 mmHg systolic or ≥ 120 mmHg
diastolic) within 6 months before starting study treatment
6. Pericarditis or pericardial effusion that is symptomatic within 6 months before
starting study treatment
5. Pulmonary disease including idiopathic pulmonary fibrosis, noninfectious interstitial
lung disease, pneumonitis, chronic obstructive pulmonary disease (requiring daily
treatment for dyspnea, oxygen therapy on an ongoing basis, or hospitalization within
the past 6 months)
6. Hepatic disease resulting in symptomatic ascites, encephalopathy, coagulopathy,
esophageal/gastric varices, or persistent jaundice
7. Arterial thrombotic event, stroke, or transient ischemia attack within 6 months before
starting study treatment
8. Bleeding diathesis or uncontrolled bleeding within 7 days before starting study
treatment
9. Bone marrow transplant or solid organ transplant
10. Infection including:
1. Disease requiring systemic therapy within 7 days before starting study treatment
2. Ongoing COVID-19 as determined by viral testing
3. Active human immunodeficiency virus (HIV) infection as determined at screening
4. Active hepatitis B infection as determined at screening
5. Active hepatitis C infection as determined at screening
11. Autoimmune disease requiring systemic disease-modifying or immunosuppressive therapy
within 2 years before starting study treatment. Exceptions include disease managed
with only replacement therapies (eg, thyroxine, etc.)
12. History of hemophagocytic lymphohistiocytosis/macrophage activation syndrome
13. Malignancy within 2 years before starting study treatment other than the disease under
study. Exceptions include indolent or definitively treated disease not expected to
require treatment during the study, affect the safety of subjects, or affect the
endpoints of the trial
14. Any medical condition requiring corticosteroids (> 10 mg daily oral prednisone or
equivalent) or other systemic immunosuppressive therapy within 28 days before starting
study treatment. Exception: Intermittent or sporadic use of inhaled or topical
steroids is allowed
15. Residual toxicity from previous treatment including:
1. Toxicity related to prior treatment not resolved to Grade 1
2. Neuropathy Grade > 2 Note: Exceptions to the above criteria include toxicities
that do not pose a risk to vital organ systems (eg, alopecia) or toxicities that
are stable as managed by replacement therapies (eg, hypothyroidism)
16. Subjects receiving immune checkpoint inhibitor: Toxicity Grade 3 related to prior
immunotherapy and leading to treatment discontinuation
17. Any investigational agent within 28 days before starting study treatment or within 5
estimated elimination half-lives, whichever is shorter
18. Radiation therapy within 14 days before starting study treatment
19. History of severe hypersensitivity to any ingredient of BDC-3042 or study treatment
(as applicable for combination study treatment)
20. Received live/attenuated virus vaccine within 28 days before starting study treatment
21. Major surgery within 28 days of starting study treatment (consult with Medical
Monitor)
22. Actively enrolled in another clinical study, unless it is an observational
(noninterventional) clinical study or the follow-up component of an interventional
study
23. Patient is a lactating mother or pregnant as confirmed by pregnancy tests within 7
days prior to start of study treatment
24. Patient is unwilling or unable to follow protocol requirements
25. Ongoing bowel perforation or presence of bowel fistula or intra-abdominal abscess
26. Any condition that, in the opinion of the Investigator, would interfere with
evaluation of BDC-3042 or interpretation of the patient's safety or study results
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Anastasia L Harper
650-725-0378
Not Recruiting